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Clinical Trial Comparing Two Protocols Using Intravenous (IV) Hydromorphone

Primary Purpose

Acute Pain

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

H2O

1+1

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring acute, pain, emergency department, hydromorphone

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age greater than 21 years and less than 65 years: This is a study of non-elderly adult patients. In addition, patients aged 21 years and younger are automatically triaged to the Children's Emergency Department (ED).
Pain with onset within 7 days: Pain within seven days is the definition of acute pain that has been used in ED literature.
ED attending physician's judgment that patient's pain warrants intravenous (IV) opioids

Exclusion Criteria:

Use of other opioids or tramadol within past 24 hours: to avoid introducing assembly bias related to recent opioid use, since this may affect baseline levels of pain and need for analgesics.
Prior adverse reaction to opioids.
Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in modulation of pain perception which is thought to be due to down-regulation of pain receptors. Examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies.
Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception.
Systolic Blood Pressure <90 mm Hg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension.
Oxygen saturation < 95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled.
Use of monoamine oxidase (MAO) inhibitors in past 30 days: MAO inhibitors have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma.
CO2 measurement greater than 46: In accordance with standard protocol, three subsets of patients will have their CO2 measured using a handheld capnometer prior to enrollment in the study. If the CO2 measurement is greater than 46 then the patient will be excluded from the study. The 3 subsets are as follows:
- All patients who have a history of chronic obstructive pulmonary disease (COPD)
- All patients who report a history of asthma together with greater than a 20 pack-year smoking history
- All patients reporting less than a 20 pack-year smoking history who are having an asthma exacerbation

Sites / Locations

Montefiore Medical Center Moses Division Emergency Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

H2O

1+1

Arm Description

2 mg IV hydromorphone administered over 2-3 minutes as initial dose

1 mg IV hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the following question: "Do you want more pain medication?"

Outcomes

Primary Outcome Measures

Number of Patients With Satisfactory Pain Management at 60 Minutes

The primary outcome is the proportion of patients in each arm who choose to forgo additional pain medication at 60 minutes. This is defined as the number of patients who declined additional pain medication at 60 minutes.

Secondary Outcome Measures

Mean Change in Pain Intensity From Baseline to 60 Minutes

Pain intensity is measured in numerical rating scale (NRS) units from 0 ("no pain") to 10 ("worst pain imaginable"). The change here represents the NRS score given by the patients at 60 minutes subtracted from the score at baseline, before treatment in the Emergency Department.

Number of Patients Who Reported no Pain or Mild Pain at 60 Minutes

Full Information

NCT ID

NCT01311895

First Posted

March 4, 2011

Last Updated

April 20, 2018

Sponsor

Montefiore Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01311895

Brief Title

Clinical Trial Comparing Two Protocols Using Intravenous (IV) Hydromorphone

Official Title

Randomized Clinical Trial Comparing Two Protocols Using IV Hydromorphone

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

January 2011 (Actual)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Montefiore Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to compare two opioid protocols ("H2O" and "1+1") for the treatment of acute severe pain in the emergency department. The investigators primary hypothesis is that the "H2O" protocol will be more efficacious than the "1+1" protocol in Emergency Department patients aged 21-64 years. The primary outcome is the proportion of patients in each arm who choose to forgo additional pain medication at 60 minutes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Pain

Keywords

acute, pain, emergency department, hydromorphone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

350 (Actual)

8. Arms, Groups, and Interventions

Arm Title

H2O

Arm Type

Experimental

Arm Description

2 mg IV hydromorphone administered over 2-3 minutes as initial dose

Arm Title

1+1

Arm Type

Experimental

Arm Description

1 mg IV hydromorphone followed by an additional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the following question: "Do you want more pain medication?"

Intervention Type

Drug

Intervention Name(s)

H2O

Other Intervention Name(s)

Dilaudid

Intervention Description

2 mg IV hydromorphone

Intervention Type

Drug

Intervention Name(s)

1+1

Other Intervention Name(s)

Dilaudid

Intervention Description

1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"

Primary Outcome Measure Information:

Title

Number of Patients With Satisfactory Pain Management at 60 Minutes

Description

Time Frame

60 minutes

Secondary Outcome Measure Information:

Title

Mean Change in Pain Intensity From Baseline to 60 Minutes

Description

Time Frame

60 minutes

Title

Number of Patients Who Reported no Pain or Mild Pain at 60 Minutes

Time Frame

60 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age greater than 21 years and less than 65 years: This is a study of non-elderly adult patients. In addition, patients aged 21 years and younger are automatically triaged to the Children's Emergency Department (ED). Pain with onset within 7 days: Pain within seven days is the definition of acute pain that has been used in ED literature. ED attending physician's judgment that patient's pain warrants intravenous (IV) opioids Exclusion Criteria: Use of other opioids or tramadol within past 24 hours: to avoid introducing assembly bias related to recent opioid use, since this may affect baseline levels of pain and need for analgesics. Prior adverse reaction to opioids. Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in modulation of pain perception which is thought to be due to down-regulation of pain receptors. Examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies. Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception. Systolic Blood Pressure <90 mm Hg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension. Oxygen saturation < 95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled. Use of monoamine oxidase (MAO) inhibitors in past 30 days: MAO inhibitors have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma. CO2 measurement greater than 46: In accordance with standard protocol, three subsets of patients will have their CO2 measured using a handheld capnometer prior to enrollment in the study. If the CO2 measurement is greater than 46 then the patient will be excluded from the study. The 3 subsets are as follows: All patients who have a history of chronic obstructive pulmonary disease (COPD) All patients who report a history of asthma together with greater than a 20 pack-year smoking history All patients reporting less than a 20 pack-year smoking history who are having an asthma exacerbation

Facility Information:

Facility Name

Montefiore Medical Center Moses Division Emergency Department

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

12. IPD Sharing Statement

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Clinical Trial Comparing Two Protocols Using Intravenous (IV) Hydromorphone

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